deltatrials
Completed PHASE3 NCT01112644

Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Placebo to Demonstrate Improvement in Symptoms of Restless Legs Syndrome (RLS) in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms

A Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate Improvement of Symptoms of RLS in Subjects With Moderate to Severe Idiopathic RLS With Daytime Symptoms Who Take OXN PR Compared to Subjects Taking Placebo (PLA).

Sponsor: Mundipharma Research GmbH & Co KG

Updated 7 times since 2017 Last updated: Oct 19, 2018 Started: Apr 30, 2010 Primary completion: Jun 30, 2011 Completion: Jun 30, 2011

A PHASE3 clinical study on Moderate to Severe Idiopathic RLS With Daytime Symptoms, this trial is completed. The trial is conducted by Mundipharma Research GmbH & Co KG and has accumulated 7 data snapshots since 2010. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshotCompleted~Nov 2018 – ~Jan 2021 · 26 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 7 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Nov 2018 — Jan 2021 [monthly]

    Completed PHASE3

Show 2 earlier versions
  1. Jun 2018 — Nov 2018 [monthly]

    Completed PHASE3

  2. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE3

    First recorded

Apr 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Mundipharma Research GmbH & Co KG
Data source: Mundipharma Research GmbH & Co KG

For direct contact, visit the study record on ClinicalTrials.gov .